Identity
- Trade Name
- SmartArm EUDAMED
- Device Name
- Limb Positioner EUDAMED
- Model / Reference
- RJ8147007 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06941832516748 EUDAMED
- Basic UDI-DI
- 69418325P2020009008A EUDAMED
- Direct Marketing DI
- 06941832516748 EUDAMED
- EMDN Code
- L0999 ORTHOPAEDIC AND TRAUMATOLOGICAL SURGERY INSTRUMENTS, REUSABLE - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
SmartArm by Hangzhou Rejoin Mastin Medical Device Co., Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 69418325P2020009008A | Class I | Active |
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Manufacturer
- Manufacturer
- Hangzhou Rejoin Mastin Medical Device Co.，Ltd.
- EUDAMED SRN
- CN-MF-000006572
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED 70a55a80-612e-43c7-8815-18cc9492273e 61 fields · synced Oct 6, 2026